NL-OMON50925尚未招募3 期
COVID-19: A Phase 2b/3, Randomized, Observer-Blinded, Placebo-Controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older. - HERALD
CureVac AG0 个研究点目标入组 2,400 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Inclusion criteria for all subjects:
- •Subjects will be enrolled in this trial only if they meet all of the following
- •1. Male or female subjects 18 years of age or older.
- •2. Be willing and able to provide written informed consent prior to initiation
- •of any trial procedures..
- •3. Expected compliance with protocol procedures and availability for clinical
- •follow-up through the last planned visit.
- •4. Females of non-childbearing potential defined as follows: surgically sterile
- •(history of bilateral tubal ligation/occlusion, bilateral oophorectomy or
- •hysterectomy) or postmenopausal {defined as amenorrhea for >= 12 consecutive
- •months prior to screening (Day 1)} without an alternative medical cause). A
- •follicle-stimulating hormone (FSH) level may be measured at the discretion of
- •the Investigator to confirm postmenopausal status.
- •5. Females of childbearing potential: negative pregnancy test {human chorionic
- •gonadotropin (hCG)} within 24 hours prior to each trial vaccination on Day 1
- •and Day 29.
- •6. Females of childbearing potential must use highly effective methods of birth
- •control from 2 weeks before the first administration of the trial vaccine until
- •3 months following the last administration. The following methods of birth
- •control are considered highly effective when used consistently and correctly:
- •Combined (estrogen and progestogen containing) hormonal contraception
- •associated with inhibition of ovulation (oral, intravaginal or transdermal);
- •Progestogen-only hormonal contraception associated with inhibition of
- •ovulation (oral, injectable or implantable);
- •Intrauterine devices;
- •Intrauterine hormone-releasing systems;
- •Bilateral tubal ligation;
- •Vasectomized or infertile partner;
- •7. Sexual abstinence {periodic abstinence (e.g., calendar, ovulation,
- •symptothermal and post-ovulation methods) and withdrawal are not acceptable}.
排除标准
- •Subjects will not be enrolled in this trial if they meet any of the following
- •1. History of virologically-confirmed COVID-19 illness.
- •2. For females: pregnancy or lactation.
- •3. Use of any investigational or non-registered product (vaccine or drug)
- •within 28 days preceding the administration of the first trial vaccine or
- •planned use during the trial.
- •4. Receipt of licensed vaccines within 28 days (for live vaccines) or 14 days
- •(for inactivated or any other vaccines) prior to the administration of the
- •first trial vaccine.
- •5. Prior administration of any investigational SARS-CoV-2 vaccine or another
- •coronavirus (SARS-CoV, MERS-CoV) vaccine or planned use during the trial.
- •6. Any treatment with immunosuppressants or other immune-modifying drugs
- •(including but not limited to anabolic steroids, corticosteroids, biologicals
- •and methotrexate) for > 14 days total within 6 months preceding the
- •administration of trial vaccine or planned use during the trial. For
- •corticosteroid use, this means prednisone or equivalent, 0.5 mg/kg/day for 14
- •days or more. The use of inhaled, topical, or localized injections of
- •corticosteroids (e.g., for joint pain/inflammation) is permitted.
- •7. Any medically diagnosed or suspected immunosuppressive or immunodeficient
- •condition based on medical history and physical examination including known
- •infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or
- •hepatitis C virus (HCV); current diagnosis of or treatment for cancer including
- •leukemia, lymphoma, Hodgkin disease, multiple myeloma, or generalized
- •malignancy; chronic renal failure or nephrotic syndrome; and receipt of an
- •organ or bone marrow transplant.
- •8. History of angioedema (hereditary or idiopathic) or history of any
- •anaphylactic reaction.
- •9. History of pIMD.
- •10. History of allergy to any component of CVnCoV vaccine.
- •11. Administration of immunoglobulins or any blood products within 3 months
- •prior to the administration of trial vaccine or planned receipt during the
- •12. Subjects with a significant acute or chronic medical or psychiatric illness
- •that, in the opinion of the Investigator, precludes trial participation (e.g.,
- •may increase the risk of trial participation, render the subject unable to meet
- •the requirements of the trial, or may interfere with the subject*s trial
- •evaluations). These include severe and/or uncontrolled cardiovascular disease,
- •gastrointestinal disease, liver disease, renal disease, respiratory disease,
- •endocrine disorder, and neurological and psychiatric illnesses. However, those
- •with controlled and stable cases can be included in the trial.
- •13. Subjects with impaired coagulation or any bleeding disorder in whom an IM
- •injection or a blood draw is contraindicated.
- •14. Foreseeable non-compliance with the trial procedures as judged by the
- •Investigator.
研究者
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